Cardiac Dimensions (Kirkland, Washington) reported that new long-term outcomes data from the TITAN II clinical trial of its enhanced Carillon Mitral Contour System showed significant and sustained improvements in mitral regurgitation, functional improvement, quality of life and reverse cardiac remodeling.

The long-term safety and efficacy data, which was consistent with previous trials of the system, was presented at the 26th annual Transcatheter Cardiovascular Therapeutics Conference in Washington, by TITAN II investigator Michael Haude of Lukaskrankenhaus in Neuss, Germany.

TITAN II was a prospective, single-arm European multi-center clinical trial initiated to further evaluate an enhanced version of the Carillon system. As a minimally-invasive therapy, the Carillon system is designed to treat heart failure patients suffering from functional mitral regurgitation (FMR), a condition in which blood flow to the body is reduced due to an abnormally enlarged mitral valve. An estimated 70% of the 20 million people worldwide with heart failure also suffer from FMR.

"This was the third multi-center perspective trial that we've done and all three trials that we have completed have been in Europe," Omari Bouknight, VP of sales and marketing Cardiac Dimensions, told Medical Device Daily. "This study was really a study of an enhanced version of the device that we've developed and we wanted to make sure that the results spoke from a safety and efficacy perspective that were similar to results we had seen in our previous two trials."

A total of 30 patients across five sites were implanted with Carillon devices and were followed for a one-year period as part of the TITAN II trial. Enrolled patients represented a severely ill advanced heart failure population at baseline, with an average New York Heart Association (NYHA) classification of III, an average left ventricular ejection fraction of 33% and an average mitral regurgitation grade of just under 3+.

"What the trial showed was that with the device, patients experienced one year of significant benefits in terms of reduction of mitral regurgitation," he said. "As a result, patients saw a significant increase in terms of their six minute walk and in terms of their heart failure symptoms."

Key findings also include; 80% of patients experienced at least a one class improvement in NYHA classification from baseline to 12 months; marked improvement in functional capacity with six-minute walk distances increasing from 294.1±82.6 to 381.6±130.3 meters at 12 months; a low 30-day major adverse event rate of 2.8%.

The system combines an implantable device with a percutaneous catheter delivery system. The implantable device consists of a proximal anchor and a distal anchor connected by a shaping ribbon. Utilizing the heart's natural structures, the device is intended to reduce mitral annulus dilatation upon deployment, thereby significantly reducing FMR. Rapidly delivered via the venous vasculature, Carillon has the potential to treat most heart failure patients in a minimally invasive fashion. Clinical data suggests that usage is associated with significant reduction in FMR, and significant improvement in functional capacity and quality of life.

"The device is designed to treat functional mitral regurgitation," Bouknight said. "This is a condition that heart failure patients experience as the heart enlarges due to the heart failure, the mitral valve enlarges."

FMR typically results from the dilation of the left ventricle, which is the main pumping chamber in the heart. As the left ventricle increases in size, the mitral valve also expands. This dimensional increase leads to mitral regurgitation, which significantly reduces the amount of blood flow out of the left ventricle and on to the body and its organs. FMR has been associated with high rates of mortality, reduced functional capacity, poor quality of life and an increase in patient hospitalizations. Current mainstream therapies to address FMR are limited. A majority of patients become refractory to medical therapy, which is the current standard of care and traditional surgical intervention is associated with high rates of operative morbidity and mortality.

The device is designed to be positioned in the coronary sinus and great cardiac vein using standard cardiac catheterization techniques. The Carillon implant is a fixed length, double anchor device designed to plicate the tissue next to the mitral valve annulus during the deployment process.

Plans now call for the company to seek U.S. approval of the device.

"The device has CE mark," Bouknight said. "In terms of approval in the U.S., the next step would be to perform an IDE trial, and we're in the process of trying to negotiate that with the FDA. We're still not quite clear what the timeline will be or when we'll be able to start the trial."